FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134665–134688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1988
MULTI-CHEMISTRY LINEARITY STANDARD
K875285 · JIX
Verichem Laboratories, Inc.
Chemistry · 248d
Cleared Sep 02, 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC
K881674 · JAK
Shimadzu Precision Instruments, Inc.
Radiology · 137d
Cleared Sep 02, 1988
RADKOR XG-325
K881696 · IZO
Radkor, Inc.
Radiology · 136d
Cleared Sep 02, 1988
RADKOR KOB-84
K881700 · KXJ
Radkor, Inc.
Radiology · 136d
Cleared Sep 02, 1988
L-F COILED EXTENSION TUBING
K882329 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 88d
Cleared Sep 02, 1988
HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900
K882365 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 86d
Cleared Sep 02, 1988
LARYNGOSCOPE RIGID
K882433 · CCW
Eastmed Enterprises, Inc.
Anesthesiology · 80d
Cleared Sep 02, 1988
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
K882496 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 77d
Cleared Sep 02, 1988
STACHROM ANTIPLASMIN TEST KIT
K882602 · GGP
American Bioproducts Co.
Hematology · 70d
Cleared Sep 02, 1988
STACHROM ANTIPLASMIN CONTROL
K882603 · GGP
American Bioproducts Co.
Hematology · 70d
Cleared Sep 02, 1988
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K883020 · JJF
Alpkem Corp.
Chemistry · 45d
Cleared Sep 02, 1988
RADKOR, XG-515
K883081 · IZO
Radkor, Inc.
Radiology · 43d
Cleared Sep 02, 1988
AMBU TWIN PUMP - (MANUAL SUCTION PUMP)
K883433 · GCY
Ambu, Inc.
General & Plastic Surgery · 18d
Cleared Sep 02, 1988
C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS
K883521 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Sep 02, 1988
GRID/RADIOGRAPHIC
K883527 · IXJ
Umi, Inc.
Radiology · 15d
Cleared Sep 02, 1988
LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)
K883599 · IEO
Innovative Medical Systems, Inc.
Pathology · 10d
Cleared Sep 01, 1988
SYRINGE PUMP MS2000
K880857 · FRN
Smash Ent., Inc.
General Hospital · 184d
Cleared Sep 01, 1988
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE
K880878 · IYX
Philips Medical Systems (Cleveland),...
Radiology · 184d
Cleared Sep 01, 1988
EXPANDED CLAIMES TO OSTEOGEN(R)
K881662 · DZE
Impladent
Dental · 139d
Cleared Sep 01, 1988
ARGYLE AUTOTRANSFUSION BAG
K882757 · CAC
Sherwood Medical Co.
Anesthesiology · 58d
Cleared Sep 01, 1988
HEARING AID, UNITRON MODEL VISTA 1000
K883513 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 15d
Cleared Aug 31, 1988
AD-HEAL(TM) WOUND DRESSING
K881731 · NAD
Nepera, Inc.
General & Plastic Surgery · 131d
Cleared Aug 31, 1988
WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM
K881779 · HSX
Dow Corning Wright
Orthopedic · 127d
Cleared Aug 31, 1988
TRACER
K881842 · BXN
Life-Tech Intl., Inc.
Anesthesiology · 121d